New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

08/31/2009

Trade Name:

Astepro Nasal Spray

Generic Name or Proper Name (*):

azelastine hydrochloride

Indications Studied:

Seasonal and perennial allergic rhinitis in patients 12 years of age and older.

Label Changes Summary:

* Safety and efficacy for the treatment of seasonal and perennial allergic rhinitis were evaluated in 7 controlled clinical trials in patients 12 years and older * Information on clinical trials, dosing, and adverse events (AEs) * New indication (PAR) and dosing regimen